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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 14 of 14. This is the beginning of the thread.
Posted by law663 on November 5, 2005, at 8:05:19
Somerset Low-Dose Emsam Does Not Need Dietary Restrictions, Committee Says
Somerset’s low-dose Emsam (selegiline) patch for major depression should be marketed without dietary restrictions, FDA’s Psychopharmacologic Drugs Advisory Committee recommended Oct 26.
“I was convinced that there’s no harm signal in either the clinical trials data that were represented or the more extensive database for the use of Eldepryl,” Committee Chair Wayne Goodman (University of Florida) said.
Furthermore, Goodman said, “benefit is clearly an issue here….We do have other [monoamine oxidase inhibitors] on the market but it’s clear to me that this is going to produce far less risk than our existing medications of having a hypertensive reaction.”
The committee voted 7-4 that the 20 mg patch could be marketed without restrictions on foods with a high tyramine content, such as cheese and red wine.
FDA initially proposed that all three strengths of Emsam require dietary restrictions; Somerset, a Mylan/Watson joint venture, has agreed to the restrictions for its 30 mg and 40 mg strengths.
High levels of tyramine, which is metabolized by MAO, lead to elevated blood pressure and possibly hypertensive crisis.
Somerset presented the committee with safety data from clinical trails covering 2,503 patients, a tyramine challenge program with 214 subjects across 14 studies and post-marketing data from currently marketed oral selegiline (Somerset’s Eldepryl and generics).
“I thought that the analysis, not only of hypertensive crisis, but of all the symptoms that can be associated with hypertension itself were looked at a number of different ways, and I don’t think that any of us saw a signal there,” committee consultant Carol Tamminga (University of Texas) said.
Committee members who voted for dietary restrictions for all dosage strengths cited small sample sizes for the tyramine challenge program studies and low patient compliance with the varied dietary requirements.
The committee also voted 6-4 that it would be acceptable to market the 20 mg patch without dietary restrictions while simultaneously requiring the restrictions for the 30 mg and 40 mg patch strengths.
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Posted: Wednesday, October 26, 2005
Posted by willyee on November 5, 2005, at 8:53:40
In reply to Emsam Update, posted by law663 on November 5, 2005, at 8:05:19
Great informative post........thanks a million!
So i might have missed it,but are we hearing anything in terms of a actual RELEASE DATE??
Posted by law663 on November 5, 2005, at 9:10:12
In reply to Re: Emsam Update, posted by willyee on November 5, 2005, at 8:53:40
the PDUFA date is Nov. 27
> Great informative post........thanks a million!
>
> So i might have missed it,but are we hearing anything in terms of a actual RELEASE DATE??
Posted by willyee on November 5, 2005, at 11:16:49
In reply to Re: Emsam Update, posted by law663 on November 5, 2005, at 9:10:12
My b-day is nov 26.......what a gift
Posted by Phillipa on November 5, 2005, at 21:21:25
In reply to Re: Emsam Update, posted by willyee on November 5, 2005, at 11:16:49
I'll be following all your threads. Fondly, Phillipa
Posted by Cecilia on November 6, 2005, at 2:03:57
In reply to Re: Emsam Update, posted by Phillipa on November 5, 2005, at 21:21:25
Having food restrictions on the 30 and 40 mg patches but not the 20 really doesn`t make a lot of sense to me. People vary enormously in the amount of drug in their systems (on ALL drugs) depending on genetic factors, metabolic factors etc.- one person might have higher blood levels on 20 mg than another on 40. Cecilia
Posted by Ame Sans Vie on November 6, 2005, at 9:01:25
In reply to Re: Emsam Update, posted by Cecilia on November 6, 2005, at 2:03:57
> Having food restrictions on the 30 and 40 mg patches but not the 20 really doesn`t make a lot of sense to me. People vary enormously in the amount of drug in their systems (on ALL drugs) depending on genetic factors, metabolic factors etc.- one person might have higher blood levels on 20 mg than another on 40. Cecilia
I totally agree with you there -- of course the food restrictions on the higher dosage forms don't have to be taken as gospel, so for now I'm just ecstatic to hear that this option will finally be available soon to so many on here who've been waiting. :-)
Fondly,
~MichaelP.S. Thanks so much to law663 for posting this!!
Posted by law663 on November 6, 2005, at 13:47:10
In reply to Re: Emsam Update » Cecilia, posted by Ame Sans Vie on November 6, 2005, at 9:01:25
Glad to post it and that there will be another option. However, I am skeptical about all new drugs. Remeber Cymbalta's early claim that it didn't have sexual side effects?
> > Having food restrictions on the 30 and 40 mg patches but not the 20 really doesn`t make a lot of sense to me. People vary enormously in the amount of drug in their systems (on ALL drugs) depending on genetic factors, metabolic factors etc.- one person might have higher blood levels on 20 mg than another on 40. Cecilia
>
> I totally agree with you there -- of course the food restrictions on the higher dosage forms don't have to be taken as gospel, so for now I'm just ecstatic to hear that this option will finally be available soon to so many on here who've been waiting. :-)
>
> Fondly,
> ~Michael
>
> P.S. Thanks so much to law663 for posting this!!
Posted by iforgotmypassword on November 6, 2005, at 15:07:54
In reply to Re: Emsam Update, posted by law663 on November 6, 2005, at 13:47:10
if EMSAM is actually effective for non-typical cases, it will not be marketed.
Posted by willyee on November 7, 2005, at 1:21:24
In reply to this situation is just to get people's hope up, posted by iforgotmypassword on November 6, 2005, at 15:07:54
Wow thats a strong statement,especialy when its some peoples last hope here,myself being one..
Why do you feel this way if i may ask?
Posted by iforgotmypassword on November 7, 2005, at 2:16:52
In reply to Re: this situation is just to get people's hope up, posted by willyee on November 7, 2005, at 1:21:24
it always seems like if a drug can help someone who's case is so resistant, they start making claims of it being abusable. :( it's almost like the government feels a neccessity to refuse to enable certain populations. but i was really feeling gross when i typed that, i'm sorry.
Posted by willyee on November 7, 2005, at 10:11:44
In reply to Re: this situation is just to get people's hope up, posted by iforgotmypassword on November 7, 2005, at 2:16:52
Im feeling more than GROSS myself,and dont have much to hang on too,that is the only reason your post caught my eye,im sure there is a lot of truth to it,but there is also a lot of truth to the love of money i mean xyrem with the abuse potential is has on its back almost as a posion! made it to the markert at a gross price range.
Maybe the hope of profit will allow deprenyl to get to us regardless of anything else but that reason alone,i dont care either,if it takes fattening up more pockets than i already personaly have to get better than i will,money no longer means much to me anymore.
Posted by Joe Schmoe on November 17, 2005, at 9:14:33
In reply to Emsam Update, posted by law663 on November 5, 2005, at 8:05:19
Can someone tell me what the different dosages are for? Do you need a higher dosage for social phobia than you do for depression, or vice-versa? Or is it just a "required dosage varies by individual" kind of thing?
I have social phobia and atypical depression/dysthymia and have had fairly good success with klonopin and lexapro, but I still feel things could be better - I can handle normal situations now but am still socially avoidant by preference and don't handle confrontations (like at work) very well at all. I'm afraid of Nardil for the usual reasons. This patch sounds like it could be a way to ditch both my current drugs and yet be as good or better than before.
Also I'm not sure what the "PDUFA date" means - how long after that (assuming it's approved) before a product typically appears at the local pharmacy?
Thanks!
Posted by law663 on November 17, 2005, at 10:48:26
In reply to Re: Emsam Update, posted by Joe Schmoe on November 17, 2005, at 9:14:33
Here are some useful websites:
http://www.fda.gov/oc/pdufa/PDUFAWhitePaper.pdf
http://www.biology.iupui.edu/biocourses/Biol540/4pipeline2k4.htm
http://neurotransmitter.net/newdrugs.html
Given the favorable review by the FDA regarding Ensam's foregoing the food restrictions, I'd expect to see Ensam on the market around Christmas time. It's hard to know exactly when a drug will be out due to numerous factors, especially the drug company's marketing/production schedules. Ensam has the promise of being a great drug, but there exist serious questions as to whether the lower dosage will be effective.
> Can someone tell me what the different dosages are for? Do you need a higher dosage for social phobia than you do for depression, or vice-versa? Or is it just a "required dosage varies by individual" kind of thing?
>
> I have social phobia and atypical depression/dysthymia and have had fairly good success with klonopin and lexapro, but I still feel things could be better - I can handle normal situations now but am still socially avoidant by preference and don't handle confrontations (like at work) very well at all. I'm afraid of Nardil for the usual reasons. This patch sounds like it could be a way to ditch both my current drugs and yet be as good or better than before.
>
> Also I'm not sure what the "PDUFA date" means - how long after that (assuming it's approved) before a product typically appears at the local pharmacy?
>
> Thanks!
This is the end of the thread.
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